Abcellera Biologics Inc (ABCL) 2025 Q2 法說會逐字稿

Good afternoon, and welcome to AbCellera's second quarter 2025 business update conference call. My name is Jason, and I'll facilitate the audio portion of today's interactive broadcast. At this time, I would like to turn the call over to Tryn Stimart, AbCellera's Chief Legal and Compliance Officer. You may begin.

下午好，歡迎參加 AbCellera 2025 年第二季業務更新電話會議。我叫傑森，我將負責今天互動廣播的音訊部分。現在，我想將電話轉給 AbCellera 的首席法律和合規官 Tryn Stimart。你可以開始了。

Thank you. Hello, everyone. Thank you for joining us for AbCellera's 2025 second quarter earnings call. I'm Tryn Stimart, AbCellera's Chief Legal and Compliance Officer. Dr. Carl Hansen, AbCellera's President and CEO; and Andrew Booth, AbCellera's Chief Financial Officer, are also on the call.

謝謝。大家好。感謝您參加 AbCellera 2025 年第二季財報電話會議。我是 Tryn Stimart，AbCellera 的首席法律和合規官。AbCellera 總裁兼執行長 Carl Hansen 博士和 AbCellera 財務長 Andrew Booth 也參加了電話會議。

During today's call, we anticipate making projections and forward-looking statements based on our current expectations and following the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995.

在今天的電話會議中，我們預計將根據我們目前的預期並遵循 1995 年《私人證券訴訟改革法案》的安全港條款做出預測和前瞻性陳述。

Our actual results may differ materially due to several factors outlined in our latest Form 10-K and subsequent Forms 10-Q and 8-K filed with the Securities Exchange Commission. AbCellera is not obligated to update any forward-looking statements, whether due to new information, future events or otherwise.

由於我們向證券交易委員會提交的最新 10-K 表格以及後續 10-Q 和 8-K 表格中概述的幾個因素，我們的實際結果可能存在重大差異。AbCellera 沒有義務更新任何前瞻性聲明，無論是由於新資訊、未來事件或其他原因。

Our presentation today, including our earnings press release and SEC filings issued earlier today are available on our Investor Relations website. The information we provide about our antibody therapy pipeline is for the benefit of the investment community, is not intended to be promotional.

我們今天的簡報，包括我們今天稍早發布的收益新聞稿和美國證券交易委員會 (SEC) 文件，均可在我們的投資者關係網站上查閱。我們提供的有關抗體療法管道的資訊是為了投資界的利益，並不旨在用於促銷。

As we transition to our prepared remarks, please note that all dollars referenced are US dollars. After our prepared remarks, we will open the lines for questions and answers. Now, I'll turn the call over to Carl.

當我們轉到準備好的演講時，請注意，所有引用的美元均為美元。在我們準備好的發言之後，我們將開放問答環節。現在，我將把電話轉給卡爾。

Thanks Tryn, and thank you, everyone, for joining us today. This quarter, we achieved a major company milestone, receiving Health Canada authorization to initiate AbCellera's first two clinical trials for ABCL635 and ABCL575.

感謝 Tryn，也感謝大家今天加入我們。本季度，我們實現了該公司的一個重要里程碑，獲得加拿大衛生部的授權，啟動 AbCellera 的首兩項 ABCL635 和 ABCL575 臨床試驗。

Today, I'm pleased to announce that dosing has begun in our Phase 1 clinical trial evaluating ABCL635 for moderate to severe vasomotor symptoms. This marks completion of the transition from a platform company to a clinical stage biotech that we committed to back in 2023.

今天，我很高興地宣布，我們已開始進行 ABCL635 治療中度至重度血管舒縮症狀的 1 期臨床試驗。這標誌著我們完成了從平台公司向臨床階段生物技術公司的轉型，實現了我們在 2023 年所承諾的目標。

After the end of the quarter, we also opened our Phase 1 clinical trial for ABCL575, and we anticipate dosing will begin shortly. I'm also pleased to announce that we have added a third program to our pipeline by advancing ABCL688 into IND-enabling studies.

本季結束後，我們也啟動了 ABCL575 的 1 期臨床試驗，預計很快就會開始給藥。我也很高興地宣布，我們已將 ABCL688 推進到 IND 支持研究中，從而將第三個項目添加到我們的管道中。

We ended the quarter with approximately $750 million in available liquidity, and we are well positioned to continue to execute on our strategy and are on track to complete our remaining goals for 2025.

本季末，我們擁有約 7.5 億美元的可用流動資金，我們已準備好繼續執行我們的策略，並有望完成 2025 年剩餘的目標。

These include; continuing to build our pipeline by advancing at least one more development candidate into IND-enabling studies, completing platform and infrastructure investments, and starting to use these capabilities in clinical manufacturing.

這些措施包括：繼續建造我們的產品線，將至少一個候選藥物推進到 IND 支援研究中，完成平台和基礎設施投資，並開始在臨床製造中使用這些功能。

ABCL635 is a potential first-in-class therapeutic antibody being developed for the non-hormonal treatment of moderate to severe vasomotor symptoms, more commonly known as hot flashes that are associated with menopause.

ABCL635 是一種潛在的首創治療抗體，正在開髮用於非荷爾蒙治療中度至重度血管舒縮症狀，通常稱為與更年期相關的潮熱。

ABCL635 is a potential next-generation NK3R antagonist designed to have both an improved safety profile and a more convenient dosing regimen. If ultimately successful, we believe it can be a highly differentiated product that would launch into a large and established market.

ABCL635 是一種潛在的下一代 NK3R 拮抗劑，旨在提高安全性並採用更方便的給藥方案。如果最終取得成功，我們相信它可以成為高度差異化的產品，並進入龐大而成熟的市場。

We successfully completed the CTA process for ABCL635 in Q2 of 2025. And today, we are pleased to announce that we have begun dosing participants. The ABCL635 Phase 1 clinical trial is a randomized, placebo-controlled, double-blind study in men and post-menopausal women with or without VMS.

我們在 2025 年第二季成功完成了 ABCL635 的 CTA 流程。今天，我們很高興地宣布，我們已經開始為參與者提供劑量。ABCL635 第 1 階段臨床試驗是一項針對患有或不患有 VMS 的男性和停經後女性的隨機、安慰劑對照、雙盲研究。

Its purpose is to evaluate safety, pharmacokinetics, pharmacodynamics and the frequency and severity of VMS with subcutaneous doses of ABCL635. The primary endpoint of the study is safety, and a key secondary endpoint is pharmacokinetics.

其目的是評估皮下注射 ABCL635 的安全性、藥物動力學、藥效學以及 VMS 的頻率和嚴重程度。研究的主要終點是安全性，關鍵的次要終點是藥物動力學。

As I mentioned on the last earnings call, we believe the main scientific risk for ABCL635 is whether or not we can achieve sufficient target engagement. We expect this will be addressed through biomarker and proof-of-concept studies that are part of our Phase 1 design. As previously stated, we expect initial safety and efficacy data from this trial in mid-2026.

正如我在上次收益電話會議上提到的，我們認為 ABCL635 的主要科學風險是我們是否能夠實現足夠的目標參與。我們期望透過第一階段設計中的生物標記和概念驗證研究來解決這個問題。如前所述，我們預計該試驗的初步安全性和有效性數據將於 2026 年中期公佈。

Turning to our second program, ABCL575, we received authorization from Health Canada in May to initiate a Phase 1 clinical trial. The trial was opened in July, and we anticipate dosing our first participants this quarter.

談到我們的第二個計畫 ABCL575，我們在 5 月獲得加拿大衛生部的授權，啟動第一階段臨床試驗。該試驗於 7 月開始，我們預計本季將為第一批參與者提供藥物。

This is a double-blind, placebo-controlled study designed to assess safety and tolerability in healthy participants following subcutaneous doses of ABCL575. ABCL575 is an investigational antibody therapy targeting OX40 ligand that is being developed for the treatment of moderate to severe atopic dermatitis and which also has broad potential in several other I&I indications.

這是一項雙盲、安慰劑對照研究，旨在評估健康參與者皮下注射 ABCL575 後的安全性和耐受性。ABCL575 是一種針對 OX40 配體的在研抗體療法，正在開髮用於治療中度至重度異位性皮膚炎，並且在其他幾種 I&I 適應症中也具有廣闊的潛力。

We recently presented preclinical data, which demonstrates it has potent functional activity in vitro that is in line with amlitelimab as measured by cytokine responses across a variety of cytokines, including IL-13, IL-5 and IL-9.

我們最近公佈了臨床前數據，顯示它在體外具有強大的功能活性，與 amlitelimab 一致，透過對多種細胞因子（包括 IL-13、IL-5 和 IL-9）的細胞激素反應進行測量。

As a reminder, ABCL575 is engineered with half-life extension to support less frequent dosing. Based on PK data we have obtained from studies in FcRn humanized mice, we predict a human half-life of approximately 67 days.

提醒一下，ABCL575 採用延長半衰期的設計，以支持減少給藥頻率。根據我們從 FcRn 人源化小鼠研究中獲得的 PK 數據，我們預測人類半衰期約為 67 天。

Using this half-life, our modeling predicts that a 300 milligram dosing of ABCL575 every six months should achieve circulating concentrations that remain above the efficacy threshold that was observed for amlitelimab. This prediction, once confirmed in clinical studies, would support a product profile with subcutaneous dosing once every six months.

利用這個半衰期，我們的模型預測每六個月服用 300 毫克 ABCL575 應能達到高於 amlitelimab 療效閾值的循環濃度。這項預測一旦在臨床研究中得到證實，將支持每六個月進行一次皮下注射的產品方案。

In addition to our clinical programs, we continue to allocate significant resources to internal discovery to build out our pipeline. This quarter, we advanced ABCL688 into IND and CTA-enabling studies.

除了我們的臨床項目外，我們還繼續分配大量資源用於內部發現，以建立我們的產品線。本季度，我們將 ABCL688 推進到 IND 和 CTA 支持研究。

ABCL688 is a potential antibody medicine for an undisclosed indication in autoimmunity. It is the third program in our pipeline and the second program derived from our GPCR and ion channel platform.

ABCL688 是一種潛在的抗體藥物，用於治療自體免疫疾病，具體適應症尚未公開。這是我們研發管線中的第三個項目，也是源自於我們的 GPCR 和離子通道平台的第二個項目。

Similar to ABCL635, for strategic reasons, we will not be disclosing additional information on ABCL688 until this program reaches the clinic. Our intent is to submit an IND in mid-2026.

與 ABCL635 類似，出於戰略原因，在該計畫進入臨床之前，我們不會透露有關 ABCL688 的更多資訊。我們的目標是在 2026 年中期提交 IND。

For the remainder of the year, our priorities are as follows: executing on our clinical studies with ABCL635 and ABCL575; moving ABCL688 forward in IND-enabling studies; advancing a fourth program from discovery into our pipeline; and finally, bringing our clinical manufacturing capabilities online.

在今年剩餘時間裡，我們的重點如下：執行 ABCL635 和 ABCL575 的臨床研究；推進 ABCL688 的 IND 支持研究；將第四個項目從發現階段推進到我們的研發管線；最後，將我們的臨床製造能力上線。

And with that, I'll hand it over to Andrew to discuss our financials. Andrew?

說完這些，我會把話題交給安德魯來討論我們的財務狀況。安德魯？

Thanks, Carl. As Carl pointed out, AbCellera continues to be in a strong liquidity position with approximately $580 million in cash and equivalents and with roughly $170 million in available committed government funding to execute on our strategy.

謝謝，卡爾。正如卡爾所指出的，AbCellera 繼續保持強勁的流動性狀況，擁有約 5.8 億美元的現金和等價物，以及約 1.7 億美元的可用政府承諾資金來執行我們的策略。

We are continuing to execute on our plans with a focus on internal programs and on completing our CMC and GMP investments. Looking at our business metrics. In the second quarter, we started work on five partner-initiated programs, which takes us to a cumulative total of 102 programs with downstream participation.

我們將繼續執行我們的計劃，重點關注內部專案以及完成我們的 CMC 和 GMP 投資。查看我們的業務指標。第二季度，我們啟動了由五個合作夥伴發起的項目，這使我們累計擁有 102 個下游參與的項目。

Both ABCL635 and ABCL575 received their clinical trial authorizations in the second quarter, thus advancing into the clinic. They are the first AbCellera-led molecules to reach the clinic, taking the cumulative total number of molecules to have reached the clinic, including those led by partners, to 18.

ABCL635和ABCL575均在第二季度獲得了臨床試驗授權，從而進入臨床階段。它們是第一批進入臨床的由 AbCellera 主導的分子，包括合作夥伴主導的分子在內，進入臨床的分子總數累積已達 18 個。

As we have previously stated, we view the overall progress of molecules in the clinic as a potential source of near and mid-term revenue from downstream milestone fees and royalty payments in the longer term.

正如我們之前所說，我們認為臨床中分子的整體進展是來自下游里程碑費用和長期特許權使用費的潛在近期和中期收入來源。

Turning to revenue and expenses. Revenue for the quarter was approximately $17 million, comprising of research fees relating to work on partner programs and amounts related to licensing. This compares to revenue of $7 million in the same quarter of 2024.

談到收入和支出。本季收入約為 1700 萬美元，包括與合作夥伴專案工作相關的研究費用和與許可相關的金額。相較之下，2024 年同期的營收為 700 萬美元。

The licensing fees of $10 million stems from our Trianni humanized rodent platform and mostly consists of a lump sum amount in this quarter. With respect to research fee revenue, as we have mentioned in the past, we expect these to continue to trend lower as we are increasingly focused our internal -- on internal and co-development programs.

1000 萬美元的許可費來自我們的 Trianni 人源化囓齒動物平台，大部分是本季度的一筆總款。關於研究費用收入，正如我們過去提到的，我們預計這些收入將繼續呈下降趨勢，因為我們越來越關注內部和共同開發項目。

Our research and development expenses for the quarter were approximately $39 million, $2 million less than last year. This expense reflects ongoing investment in our internal and co-development programs. The slight decrease is related to the timing of larger program-specific related expenses, which were larger in the second quarter of last year.

本季我們的研發費用約為 3,900 萬美元，比去年減少 200 萬美元。這筆費用反映了我們對內部和共同開發專案的持續投資。輕微的下降與較大項目相關費用的時間有關，這些費用在去年第二季較大。

In sales and marketing, expenses for Q2 were about $3 million, a small reduction relative to the same quarter last year. And in general and administration, expenses were approximately $19 million compared to roughly $20 million in Q2 of 2024. Included in these expenses are the ongoing expenses related to the defense of our intellectual property.

在銷售和行銷方面，第二季的支出約為 300 萬美元，與去年同期相比略有減少。一般和管理費用約為 1900 萬美元，而 2024 年第二季約為 2000 萬美元。這些費用包括與保護我們的智慧財產權相關的持續費用。

Looking at earnings, we are reporting a net loss of roughly $35 million for the quarter compared to a loss of $37 million in the same quarter of last year. In terms of earnings per share, this result works out to a loss of $0.12 per share on a basic and diluted basis.

從收益來看，我們報告本季淨虧損約為 3,500 萬美元，而去年同期的虧損為 3,700 萬美元。以每股收益計算，這一結果相當於基本和稀釋後每股虧損 0.12 美元。

Looking at cash flows. Operating activities for the first half of 2025 used approximately $44 million in cash and equivalents. Excluding investments in marketable securities, investment activities amounted to a net $36 million, mostly in property, plant and equipment, driven by the ongoing work to establish CMC and GMP manufacturing capabilities.

查看現金流。2025 年上半年的經營活動使用了約 4,400 萬美元的現金和等價物。不包括對有價證券的投資，投資活動淨額為 3,600 萬美元，主要用於房地產、廠房和設備，這得益於持續建立 CMC 和 GMP 製造能力的工作。

The investments in PP&E were partially offset by government contributions. As a part of our treasury strategy, we have about $460 million invested in short-term marketable securities. Our investment activities for the quarter included an approximately $12 million net increase in these holdings.

政府撥款部分抵消了對 PP&E 的投資。作為我們財務策略的一部分，我們已在短期有價證券上投資了約 4.6 億美元。我們本季的投資活動包括這些持股淨增加約 1,200 萬美元。

Altogether, we finished the quarter with $580 million of cash, cash equivalents and marketable securities. As a reminder, we have received commitments for funding for our GMP facility and the advancement of our internal pipeline from the Government of Canada's Strategic Innovation Fund and the Government of British Columbia. This available capital does not show up on our balance sheet.

整體而言，本季我們擁有 5.8 億美元的現金、現金等價物和有價證券。提醒一下，我們已從加拿大政府戰略創新基金和不列顛哥倫比亞省政府獲得為我們的 GMP 設施和內部管道推進提供資金的承諾。這筆可用資本並未出現在我們的資產負債表上。

With over $580 million in cash and equivalents and the unused portion of our secured government funding, we have around $750 million in total available liquidity to execute on our strategy.

我們擁有超過 5.8 億美元的現金和等價物以及我們擔保的政府資金中未使用的部分，總共擁有約 7.5 億美元的可用流動資金來執行我們的策略。

The cash usage for the remainder of 2025 will continue to prioritize advancing our 2 lead programs through their Phase 1 clinical studies, building the preclinical pipeline and completing our investment in the integrated clinical manufacturing capabilities.

2025 年剩餘時間的現金使用將繼續優先推進我們的兩個主要項目，完成其第 1 階段臨床研究，建立臨床前管道，並完成我們對綜合臨床製造能力的投資。

Our new manufacturing facility is on track to come online at the end of 2025, as we had indicated in previous calls. With respect to our overall operating expenditures, our capital needs continue to be very manageable.

正如我們在先前的電話會議中所指出的，我們的新製造工廠預計將在 2025 年底投入使用。就我們的整體營運支出而言，我們的資本需求仍然非常可控。

We continue to believe that we have sufficient liquidity to fund well beyond the next three years of increasing pipeline investments. And with that, we'll be happy to take your questions.

我們仍然相信，我們擁有足夠的流動資金來為未來三年增加的管道投資提供資金。我們很樂意回答您的問題。

(Operator Instructions) Andrea Newkirk, Goldman Sachs.

（操作員指示）高盛的安德里亞·紐柯克 (Andrea Newkirk)。

Hi everyone, this is Tolani on for Andrea. Thanks for taking our questions and congrats on the progress this quarter. One quick one from us. Just given the recent news of the delayed PDUFA for elinzanetant, do you guys anticipate any risk to the development path for 635 from a regulatory perspective? And what do you expect regulators will be most focused on in evaluating the drug's profile as it advances in development? Thank you.

大家好，我是 Tolani，為 Andrea 報告。感謝您回答我們的問題，並對本季的進展表示祝賀。我們快速說一句。鑑於最近有關 elinzanetant 的 PDUFA 被推遲的消息，從監管角度來看，你們是否預計 635 的發展路徑會面臨任何風險？您認為，在藥物研發過程中，監管機構在評估藥物特性時最關注的是什麼？謝謝。

You were breaking up a little bit at the end of the question. I did get the first part of it. So, yes, there was a delay with elinzanetant. Our understanding is that the FDA requested additional information from Bayer, and that information is forthcoming. I think the comment suggested that there was no concern raised about the approvability.

在問題結束時，您有點崩潰了。我確實得到了它的第一部分。所以，是的，elinzanetant 確實延遲了。據我們了解，FDA 已向拜耳公司請求提供更多信息，並且這些信息即將提供。我認為該評論表明沒有人對可批准性提出擔憂。

And our expectation is that that would move forward to approval later this year. So beyond that, I don't think we have anything -- any special insight into that. I didn't get the last part of the question. Could you please repeat?

我們預計該提案將在今年稍後獲得批准。除此之外，我認為我們對此沒有任何特別的見解。我不明白問題的最後一部分。您能再說一次嗎？

Sure. Sorry about that. Yeah, I was just wondering what do you think the FDA and other regulators will be focused on in evaluating 635's profile as it moves forward in clinical development?

當然。很抱歉。是的，我只是想知道您認為 FDA 和其他監管機構在評估 635 在臨床開發過程中的表現時會關注什麼？

Sure. So, there's now, I think, a well-tried path for the NK3R class, both with fezolinetant and elinzanetant. Obviously, we need to demonstrate efficacy. As I mentioned in my prepared remarks, we're excited about the upcoming data and the readout midpoint next year that should give us a lot of information about the efficacy and target engagement, which we do see as the primary scientific risk.

當然。因此，我認為現在對於 NK3R 類藥物來說，有一條經過充分驗證的途徑，包括使用 fezolinetant 和 elinzanetant。顯然，我們需要證明其有效性。正如我在準備好的發言中提到的那樣，我們對即將公佈的數據和明年的中期讀數感到興奮，這些數據應該會為我們提供大量有關功效和目標參與的信息，我們確實將其視為主要的科學風險。

On the safety side, as I mentioned on the last call, so far, what has been seen in the class for NK3R antagonist is some liver toxicity or at least signal of liver toxicity as well as somnolence or sleepiness.

在安全性方面，正如我在上次電話會議中提到的，到目前為止，在 NK3R 拮抗劑類藥物中已經觀察到一些肝毒性或至少有肝毒性信號以及嗜睡或困倦。

We believe the somnolence is because of targeting not just NK3R but also NK1R, which our antibody does not do. So we expect that that would not be a concern. And similarly, because we are the first-in-class antibody for this indication and antibodies are not metabolized in the liver as our small molecules, and because there is little evidence of expression of NK3R in the liver, we don't expect that there will be liver tox associated with our drug.

我們認為嗜睡是因為我們不僅針對 NK3R，還針對 NK1R，而我們的抗體卻沒有做到這一點。因此我們預計這不會是一個問題。同樣，由於我們是針對該適應症的首創抗體，並且抗體不會像我們的小分子一樣在肝臟中代謝，而且由於幾乎沒有證據表明 NK3R 在肝臟中表達，因此我們預計我們的藥物不會產生肝毒性。

But of course, we need to demonstrate that in the trial. And I'm sure the regulators, as the investment community will be looking at the two main things, which we always look at, which is efficacy and safety.

但當然，我們需要在審判中證明這一點。我相信監管機構和投資界將關注我們始終關注的兩個主要問題，即功效和安全性。

I have a couple. Thank you.

我有一對。謝謝。

Srikripa Devarakonda, Truist.

Srikripa Devarakonda，Truist。

Hey guys, thank you so much for taking my question, and congratulations on the progress of quarter. So, for the ABCL635 Phase 1 trial, congrats, first of all, on getting the trial initiated efficiently.

嘿，大家好，非常感謝你們回答我的問題，並祝賀本季的進展。因此，對於 ABCL635 第 1 階段試驗，首先恭喜您有效率地啟動試驗。

But now that you've initiated the trial, can you talk a little bit more about the specifics? Is there a certain -- what the total number of patients and if there is a certain ratio of healthy men to postmenopausal women you expect to enroll?

但現在您已經開始試驗，能否再多談談具體情況？您預期招募的患者總數是否一定，以及健康男性與停經後女性的比例是否一定？

And, Adam, maybe a bit more broader question. You had previously said that 50% of menopausal women are hesitant to take HRT because of the concerns around the consequences. With Dr. Makary being -- he seems to be a very strong proponent of HRT, do you think this might change the way -- the market overall? Or do you think it's -- you still have a substantial market?

亞當，也許這是一個更廣泛的問題。您之前曾說過，50% 的更年期女性因擔心後果而猶豫是否要接受 HRT。由於 Makary 博士似乎是 HRT 的堅定支持者，您認為這可能會改變整個市場嗎？或者您認為—您仍然擁有龐大的市場？

Sure. So first off, I'll maybe provide a little bit more information on the clinical trial. So, as you might expect, the first parts of the trial are basically a single ascending dose, then a multiple ascending dose.

當然。首先，我可能會提供更多有關臨床試驗的資訊。因此，正如您所預料的那樣，試驗的第一部分基本上是單次遞增劑量，然後是多次遞增劑量。

And the single ascending dose will include both menopausal men -- pardon me, that would be difficult to recruit. We will include both menopausal women and healthy men or healthy male volunteers. And in that part of the trial, we will be able to assess some biomarkers.

單次遞增劑量將包括兩名更年期男性——對不起，這將很難招募。我們將包括更年期女性和健康男性或健康男性志工。在試驗的這一部分，我們將能夠評估一些生物標記。

In the MAD, we will be recruiting only postmenopausal women. And the combination of the SAD and the MAD could be roughly 56, 60 patients or so. Once we progress on to the proof-of-concept, we expect to enroll up to 80 patients. And in that case, in that phase of the study, we will, of course, be recruiting post-menopausal women with moderate to severe VMS.

在 MAD 中，我們將只招募停經後女性。SAD 和 MAD 加起來大約有 56 到 60 名患者。一旦我們取得概念驗證的進展，我們預計將招募多達 80 名患者。在這種情況下，在研究的這個階段，我們當然會招募患有中度至重度 VMS 的停經後婦女。

So to the second part of your question, there has been some discussion lately about the use of menopausal hormone therapy and some revisiting of the women's health study. That was a study that I think cast a bit of a shade on the benefits of menopausal hormonal therapy for the treatment of VMS and other symptoms related to menopause.

對於你問題的第二部分，最近有一些關於使用更年期荷爾蒙療法的討論以及對婦女健康研究的重新檢視。我認為這項研究對更年期荷爾蒙療法對治療 VMS 和其他與更年期相關的症狀的益處有所質疑。

Our view has always been that the NK3R class is not in competition with hormone therapies. So it turns out that there are roughly 20% of the eligible population that either have contraindications, so have risk factors that mean they're not eligible for hormone therapy or that try hormone therapy and are unable to continue. So 20% of the population for which hormone therapy is not meeting their needs.

我們的觀點始終是 NK3R 類藥物並不與荷爾蒙療法構成競爭。因此，事實證明，大約有 20% 的符合條件的人群要么有禁忌症，要么有風險因素，這意味著他們不適合接受激素治療，或者嘗試過激素治療但無法繼續。因此，20% 的人口的荷爾蒙療法無法滿足他們的需求。

And then, of course, there's some other portion of the 80% that are going to have a preference not to use hormone therapy. So if you look at the number of eligible patients in the US alone, that's a very large patient population. And we would need to only capture a relatively small portion of that market to have this drug be a terrific success.

當然，這 80% 中還有一部分人不願意使用荷爾蒙療法。因此，如果只看美國符合條件的患者數量，就會發現這是一個非常龐大的患者群體。我們只需要佔領相對較小的部分市場，就能讓這種藥物獲得巨大的成功。

And so we're still very confident about the market opportunity. And we expect the conversation about MHT will continue as it should and that doesn't change our view of the market since we sort of had that in mind from the very beginning.

因此，我們仍然對市場機會非常有信心。我們預計有關 MHT 的討論將會繼續下去，這不會改變我們對市場的看法，因為我們從一開始就考慮到了這一點。

Okay. Great. Thank you so much for the color. Really helpful.

好的。偉大的。非常感謝你提供的顏色。真的很有幫助。

Faisal Khurshid, Leerink Partners.

Faisal Khurshid，Leerink Partners。

Hey guys, thank you for taking the question. I really appreciate it. I just wanted to ask on the partnership and licensing revenue for the quarter. It seems a little bit higher than kind of where you've been. Should the expectation kind of going forward or how should we think about sort of the cadence and sequencing of those funds coming in? Thank you.

嘿夥計們，謝謝你們回答這個問題。我真的很感激。我只是想詢問本季度的合作夥伴關係和授權收入。它似乎比你去過的地方稍微高一點。預期是否應該繼續發展，或者我們應該如何考慮這些資金流入的節奏和順序？謝謝。

Yeah, good question. This is Andrew here speaking, Faisal. No, you should not -- this was definitely a one-off payment really related to activities post the acquisition of Trianni that were completed really as an earn-out to the former shareholders of Trianni.

是的，好問題。我是安德魯，費薩爾。不，你不應該——這絕對是一次性付款，實際上與 Trianni 收購後的活動有關，這些活動實際上是作為對 Trianni 前股東的收益而完成的。

So you'll see, in addition to the $10 million licensing revenue, a change in the contingent consideration on our balance sheet, which is really the balancing entry related to that transaction. So it's not something that we would expect to have happen in the future.

因此，您會看到，除了 1000 萬美元的許可收入之外，我們的資產負債表上的或有對價也發生了變化，這實際上是與該交易相關的平衡分錄。所以這不是我們期望未來會發生的事情。

Got it. Thank you.

知道了。謝謝。

Malcolm Hoffman, BMO.

馬爾科姆·霍夫曼，BMO。

Hi, Malcolm Hoffman on for Evan Seigerman from BMO. Can you remind us what key efficacy data we should be looking out for in the 635 Phase 1 study? I understand we're largely looking for safety in a Phase 1, but what biomarker efficacy measures would start to give us kind of confidence in the further development here from a competitive perspective? Thanks.

大家好，我是 BMO 的 Malcolm Hoffman，取代 Evan Seigerman。您能否提醒我們在 635 第 1 階段研究中應該關注哪些關鍵療效資料？我知道我們主要在第一階段尋求安全性，但從競爭的角度來看，哪些生物標記功效測量能讓我們開始對進一步的發展充滿信心？謝謝。

Sure. So Carl here. So early in the study, we will be assessing some biomarkers, so LH and FSH in men and women. In the SAD, where there will be only healthy volunteers, participating men and women. Obviously, in the men, we'll be able to assess testosterone, and in the women estradiol.

當然。卡爾在這裡。因此，在研究的早期階段，我們將評估一些生物標記物，即男性和女性的 LH 和 FSH。在 SAD 中，只有健康的志工、男性和女性參與。顯然，對於男性，我們能夠評估睪固酮，對於女性，我們能夠評估雌二醇。

So all of those, I think are a really positive indication, and we expect to see those biomarkers modulated by treatment at the higher doses. So that's a first check, but that is not equal to efficacy.

所以我認為所有這些都是一個非常積極的跡象，我們期望看到這些生物標記透過更高劑量的治療來調節。這是第一次檢查，但這並不等於有效。

So the real measure of efficacy needs to wait until the POC study. And as I mentioned, we will be enrolling up to 80 post-menopausal women with moderate to severe VMS. And there, we're going to be assessing the frequency and severity of VMS, which is self-reported.

因此，真正衡量療效還需要等到 POC 研究。正如我所提到的，我們將招募多達 80 名患有中度至重度 VMS 的停經後女性。我們將評估自我報告的 VMS 的頻率和嚴重程度。

And so we won't have that data until sometime in mid-2026. But we think that, that study is sufficiently powered to give us coming out of that, if it lines up the way that we hope and expect, a lot of confidence that we've got something that looks like a drug and that we intend to move forward.

因此，我們要到 2026 年中期才能獲得這些數據。但我們認為，如果這項研究的結果符合我們的希望和期望，我們就有足夠的信心相信我們已經得到了一種類似藥物的東西，並且我們打算繼續前進。

Appreciate it. Thanks guys.

非常感謝。謝謝大家。

Jacqueline Kisa, TD Securities.

道明證券的 Jacqueline Kisa。

Hey guys. I think it's supposed to be Brendan. I think you have Brendan from TD Securities on. Sorry about the confusion there. Good color. It's great to see the VMS asset moving along. I actually just wanted to maybe ask another follow-up on that, actually, just related to target dosing in any respect.

嘿，大家好。我認為應該是布倫丹。我認為您聯繫的是道明證券的布倫丹。很抱歉造成混淆。顏色不錯。很高興看到 VMS 資產不斷進步。我實際上只是想就此再問一個後續問題，實際上只是與目標劑量有關。

I fully appreciate that it's still early days. A lot to kind of understand with some of the biomarker data and what that realistically means for kind of uptake down the road. But are there any special considerations when you're thinking about formulation or frequency of dosing that could kind of help as you're thinking about clinical plan down the road and then just any ability to kind of target these kinds of patients from a commercial standpoint?

我完全明白現在還為時過早。我們需要了解許多生物標記數據，以及這些數據對於未來吸收的實際意義。但是，當您考慮配方或給藥頻率時，是否有任何特殊考慮可能會對您未來的臨床計劃有所幫助，然後從商業角度針對這類患者的能力？

Yeah. I'm happy to give a little bit of color on that. So a lot of this rests on our preclinical work from which we believe that we've got an antibody that has a half-life and a potency that would support once monthly dosing on a single subcutaneous dose. And that subcutaneous dose would be a high concentration formulation at 150 mgs per ml at 2 mls. So remains to be seen.

是的。我很高興能對此作出一點解釋。因此，這在很大程度上取決於我們的臨床前工作，我們相信我們已經獲得了一種抗體，其半衰期和效力可以支持每月一次的單次皮下給藥。且皮下劑量將是高濃度配方，濃度為 2 毫升，每毫升含 150 毫克。仍有待觀察。

But based on what we've seen so far, we've got a molecule we believe hits that TPP. And of course, that's one of the things we're going to be testing both in the efficacy and in the bioavailability and PK data that will come out of the Phase 1 study.

但根據我們目前所看到的情況，我們相信有一種分子能夠擊中 TPP。當然，這是我們將在第一階段研究中測試其功效、生物利用度和 PK 數據的內容之一。

Okay, got it. Great, makes sense. Thanks guys.

好的，明白了。很好，很有道理。謝謝大家。

Stephen Willey, Stifel.

史蒂芬威利（Stephen Willey），Stifel。

Hey, thanks for taking the question. This is Josh on for Steve, and congrats on the progress. So, I noticed the healthy volunteer trial for 575 is now posted at clinicaltrials.gov. I noticed there was one Canadian site listed.

嘿，謝謝你回答這個問題。我是喬希 (Josh)，代表史蒂夫 (Steve) 祝賀他的進步。我注意到，575名健康志願者的試驗結果現在已發佈在clinicaltrials.gov網站上。我注意到其中有一個加拿大網站被列出。

And I guess just looking forward as like a longer-term strategy, do you plan on activating any US sites beyond Phase 1? Is this kind of related to like a capital commitment contingency with the governments of Canada and British Columbia to run all your trials in Phase 1 in Canada first? And then I just have a follow-up.

我想，從長期戰略的角度來看，您是否計劃在第一階段之後啟動任何美國站點？這是否與加拿大和不列顛哥倫比亞省政府的資本承諾應急計劃有關，以便首先在加拿大進行第一階段的所有試驗？然後我再跟進。

Yeah. So we have activated a site in Canada that's an expert in dermatology. We are very pleased with that site, and we think they have full capabilities to execute the Phase 1 study. Right now, our focus is on that.

是的。因此，我們在加拿大建立了一個皮膚病學專家網站。我們對網站非常滿意，我們認為他們完全有能力執行第一階段的研究。現在，我們的重點就在於此。

From our perspective, the big thesis around 575 is our belief that the OX40 ligand class is going to be an immense class, not just in atopic dermatitis, but in other autoimmune and inflammatory conditions.

從我們的角度來看，圍繞 575 的重要論點是，我們相信 OX40 配體類將成為一個巨大的類，不僅在異位性皮膚炎中，而且在其他自體免疫和發炎條件下。

We think that the key readout we're going to get in the near term is going to be bioavailability and PK, confirming some of the preclinical work we've done and the modeling that I showed during my prepared remarks.

我們認為，我們近期將獲得的關鍵讀數將是生物利用度和 PK，從而證實我們所做的一些臨床前工作以及我在準備好的發言中展示的模型。

And that the other big catalysts are going to come from outside of the company, in particular, some of the clinical development with amlitelimab and other molecules in the class that are moving forward.

其他重要催化劑將來自公司外部，特別是 amlitelimab 和同類其他分子的一些臨床開發正在推進。

So we are currently focused on that. We are also beginning to engage with the FDA and lay the foundation for the Phase 2 studies, which you would likely expect to include US sites, but we haven't triggered that yet, and we have some time before we need to.

所以我們目前專注於此。我們也開始與 FDA 合作，為第二階段研究奠定基礎，您可能會期望該研究包括美國的站點，但我們尚未啟動該研究，而且在需要之前我們還有一些時間。

Great. Thanks. And then just a follow-up. I know it's early. You said you won't really disclose any details around 688 for now. But could you maybe speak to some of the autoimmune indications of interest you might be considering for this asset?

偉大的。謝謝。然後只是後續行動。我知道還早。您說過您目前不會透露有關 688 的任何細節。但是，您能否談談您可能正在考慮的針對該資產的一些自體免疫適應症？

Yeah, I'm afraid we're going to hold this one close to our chest for strategic reasons. What I will say is that this is a program that we're very bullish on. I'd put it in a similar category to ABCL635. It's one where we have a high conviction in the biology and where we think we can get some meaningful data early on.

是的，恐怕出於戰略原因，我們會將這個問題保密。我想說的是，我們非常看好這個項目。我會把它歸類在與 ABCL635 類似的類別。我們對生物學有著很高的信心，並且認為我們可以儘早獲得一些有意義的數據。

It's got a bit of a different competitive dynamic, but it's also a program that we intend to move very quickly. And so our focus right now is getting that to the clinic as quickly as possible. And when we do, we'll be able to share more details with you. So sorry for being a little bit reticent on details, but I think it's probably in the best interest of the program.

它有一點不同的競爭態勢，但這也是我們打算快速推進的一個項目。因此，我們現在的重點是盡快將其推向臨床。當我們這樣做時，我們將能夠與您分享更多詳細資訊。很抱歉我對細節有些沉默，但我認為這可能符合該計劃的最佳利益。

No worries. Thanks guys.

不用擔心。謝謝大家。

It looks like there are no more questions. So I'll pass the call back over to the management team for closing remarks.

看起來好像沒有其他問題了。因此，我將把電話轉回給管理團隊，請他們發表最後發言。

Just to say thank you, everyone, for the support, and for joining us today, and we look forward to updating you as we progress from where we are today into the clinic. Thanks very much.

只是想對大家的支持和今天的加入我們表示感謝，我們期待從今天的狀態向診所更新進展。非常感謝。

That concludes the conference call. Thank you for your participation. Enjoy the rest of your day.

電話會議到此結束。感謝您的參與。享受剩餘的一天。